Contact A Lawyer
Have A Potential Case Reviewed By An Attorney
As information continues to emerge about the risk of cancer being spread during a laparoscopic hysterectomy with morcellation, a new investigative report suggests that policy recommendations issued in support of power morcellator use by a group of surgeons may have been improperly influenced by manufacturers of the controversial devices.
In April 2014, the FDA issued a statement about the risk of power morcellators spreading uterine cancer, indicating that the devices used during minimally invasive, laparoscopic procedures should be avoided since there is no way for doctors to determine which women may have cancer hidden within their uterus.
Power morcellators are medical devices that allow the surgeon to cut up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. However, for women with unsuspected sarcoma, the devices may spread of cancerous tissue throughout the body, rapidly upstaging the aggressive cancer.
Following the FDA warnings, a policy guideline on morcellation was issued in support of the devices by the AAGL, once known as the American Association of Gynecologic Laparoscopists, indicating that the devices are generally safe.
The gynecologic surgery group suggested that the benefits provided by minimally invasive procedures that can be performed with a power morcellator justify the small risk of cancer being spread.
A recent report by the Wall Street Journal raises questions about the industry influence on the policy statement, indicating that the AAGL violated their own conflict of interest rules, by allowing an executive officer who had been paid by a morcellator manufacturer, to help write the guidance on use of the controversial devices.
At the time the policy statement was issued and sent to AAGL members, it was not disclosed that the guidance was formed with input from Arnold Advincula, who had been a consultant for Blue Endo, which is one of a handful of companies that manufacture and sell power morcellators.
According to e-mails obtained by the Wall Street Journal, Advincula’s participation in the final discussions of the policy raised red flags among other AAGL members, and the AAGL president at the time, Ceana Nezhat, warned the organization’s executive director and medical director that Advincula’s participation was a violation of the group’s conflict of interest policies.
In 2014, Advincula declared that he had received at least $50,000 from Blue Endo for consulting services over the prior year.
A year beforehand, Advincula had been one of the group’s members who lobbied for an exemption to a policy that forbid AAGL board members from doing paid work for drug or medical device manufacturers. Advincula was able to get a “grandfather clause” added in that meant the rule did not apply to himself and other incumbent board members.
Two months after the AAGL released its morcellator policy guidance, another former AAGL president, Andrew Brill, was forced to step down from an FDA advisory panel investigating power morcellators, after it was revealed that he too had been a paid consultant for a morcellator manufacturer. The information did not come to light until another Wall Street Journal report revealed Brill’s consulting connections.
That FDA advisory panel found that there was no safe way to use power morcellators without putting women at risk of spreading and upstaging undiagnosed uterine cancer, such as sarcoma and leiomyosarcoma.
In November, the FDA decided to place a black box label warning on all power morcellators, warning of the risk of spreading cancer and contraindicating the use of the devices on most likely patients.
Power Morcellator Cancer Concerns
FDA estimates suggest up to one in 350 women undergoing a laparoscopic hyesterecomy or fibroid removal may have this unsuspected uterine cancer, which doctors are unable to detect or diagnose before the procedure.
While it is rare, these estimates have been confirmed by several subsequent studies and the spread of the aggressive cancer may be a virtual death sentence for women, greatly reducing the chances for long-term survival and rapidly diminishing their overall quality of life.
In recent months, a growing number of women and families nationwide have been filing power morcellator cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have ben provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.